Alex Delaney-Gesing 

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Watch the previous installments in this series:


What keeps you up at night in ophthalmology?

What keeps you up at night in ophthalmology: Part II

What keeps ophthalmologists up at night: Part III

What keeps ophthalmologists up at night: Part IV

What keeps you up at night in ophthalmology: Part V

What keeps you up at night in ophthalmology: Part VI


What keeps you up at night in ophthalmology: Part VII


What keeps you up at night in ophthalmology: Part VIII

Videos

Michael Rivers, MD, director of ophthalmology, Modernizing Medicine, shares what lingers on his mind in the field of ophthalmology at the end of the day. 

 What keeps you up at night in ophthalmology: Part 9

Bausch + Lomb and Clearside Biomedical announced Monday that the U.S. Food and Drug Administration (FDA) has approved XIPERE

(triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. 

 the first — and currently only — therapy utilizing suprachoroidal to treat macular edema associated with uveitis, according to Joseph C. Papa, chairman and CEO of Bausch Health, 

XIPERE is designed to provide treatment via the suprachoroidal administration with the proprietary SCS Microinjector® developed by Clearside Biomedical, the news release stated. 

The microinjector works by targeting and compartmentalizing delivery and higher proportions of absorption that is relative to intravitreal injection. 

Three clinical programs investigated XIPERE™: PEACHTREE, a randomized, multi-center, double-masked, sham-controlled phase clinical trial; MAGNOLIA, a multi-center, non-interventional extension study; and AZALEA, an open-label safety trial.

FDA approval was based on results from the PEACHTREE trial, which included 160 patients diagnosed with macular edema associated with uveitis.  XIPERE™ is also the first — and only — treatment for uveitic macular edema to demonstrate clinical efficacy with a best corrected visual acuity (BCVA) primary endpoint, according to the release.

The primary efficacy endpoint consisted of the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up, the release stated. 

Additionally, the PEACHTREE trial found a statistically significant greater proportion of patients treated with XIPERE™ (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, p< 0.01) at Week 24, according to the release.

 XIPERE™ is expected to be available during the first quarter of 2022.

Articles

Bausch + Lomb and Clearside Biomedical announced Monday that the U.S. Food and Drug Administration has approved XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. 

 FDA approves XIPERE for treatment of macular edema associated with uveitis 

JD Schaub, chief operating officer at RVL Pharmaceuticals, shares what lingers on his mind in the ophthalmic field at the end of the day.

 What keeps you up at night in ophthalmology: Part VIII

 Sheryl Stevenson speaks with Sunir J. Garg, MD, co-director of retina research at the Wills Eye Hospital in Baltimore, Maryland, on the highlights of his presentation at the 2021 annual American Academy of Ophthalmology (AAO) meeting regarding the impact of 

universal face masking on the risk of endophthalmitis following intravitreal anti-vascular endothelial growth factor (VEGF) injections.

Sunir J. Garg, MD, speaks on the influence of COVID-19 universal face masking on the risk of endophthalmitis following intravitreal anti-VEGF injections.

Influence of universal face masks on endophthalmitis risk post-anti-VEGF injections 

John Saharek, president of ImprimisRX, speaks with Ophthalmology Times' David Hutton on three new products the company will be featuring during the American Academy of Ophthalmology's 2021 annual meeting, including:

 Moxi-Brom (moxifloxacin hydrochloride 0.5% and bromfenac sodium sesquihydrate 0.075%)

 Klarity-CL drops (cyclosporine 0.1% / loteprednol etabonate 0.2% ophthalmic suspension)

Tim-Brim-Dor-Bim (prednisolone acetate 1%, gatifloxacin 0.5%, bromfenac 0.075%).

ImprimisRx President John Saharek shares an update on a few of the company's latest products during AAO 2021. 

ImprimisRx offers a look at three new products in the pipeline 

® David Hutton speaks with Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb, on the company's latest 

(triamcinolone acetonide injectable suspension)for  the treatment of macular edema associated with uveitis. 

XIPERE is the first—and currently only— FDA-approved therapy utilizing suprachoridal administration.

Bausch + Lomb's Yolande Barnard, shares an update on the FDA approval of XIPERE for the treatment of macular edema associated with uveitis. 

Alex Delaney-Gesing

Articles

Influence of universal face masks on endophthalmitis risk post-anti-VEGF injections

ImprimisRx offers a look at three new products in the pipeline

Bausch + Lomb: Update on FDA approval of XIPERE for macular edema associated with uveitis

What keeps you up at night in ophthalmology: Part 9

FDA approves XIPERE for treatment of macular edema associated with uveitis

What keeps you up at night in ophthalmology: Part VIII